Correlation Between Postprandial Hypotension and Post-induction Hypotension in the Elderly.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorPeking Union Medical College Hospital
About this trial
Postprandial hypotension (PPH) and post-induction hypotension (PIH) are very common in the elderly population and are associated with a variety of poor outcomes.The purpose of this study is to investigate the correlation between PPH and perioperative adverse events such as PIH in the elderly.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Elderly patients (≥ 65 years old）;
Patients with American Society of Anesthesiologists(ASA) grade I-III;
Patients scheduled to undergo elective non-cardiac surgery under general anesthesia, with an anticipated surgical duration of over 1 hour；
Patients with intra-tracheal intubation following intravenous general ；anesthesia induction and maintenance；
Disqualifiers
Patients with vascular diseases such as aortic aneurysm, aortic dissection, symptomatic atherosclerotic obliterans, Buerger's disease, and Raynaud's syndrome
Patients with secondary hypertension, including renal hypertension and endocrine hypertension.
Patients with chronic kidney disease requiring dietary restrictions or dialysis.
Patients with Parkinson's disease or other conditions causing tremors.
Trial population
Elderly patients scheduled for elective non-cardiac surgery under general anesthesia in Peking Union Medical College Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 2 trial groupsGroup A: Postprandial hypotension group
Group B: No postprandial hypotension group
Trial outcomes
Primary outcomes
1
Post-induction hypotension
which is defined as systolic blood pressure (SBP) \<90 mm Hg or a decrease of more than 30% from baseline blood pressure, mean arterial pressure(MAP)\<65 mm Hg or a decrease of more than 30% from baseline blood pressure within 20 minutes after induction or before incision.
Time frame
Within 20 minutes after induction or before incision.Secondary outcomes
1
Postoperative complications
We will use the Clavien-Dindo system to grade postoperative complications.
Time frame
Within 30 days after surgery2
early intraoperative hypotension （eIOH）
which is defined asa systolic blood pressure \<90 mmHg, mean arterial pressure \<65 mmHg, or a decrease of more than 30% from baseline
Time frame
within the first 30 minutes after the start of surgery3
mortality within 30 days after surgery
we will assess the mortality by postoperative follow-up
Time frame
within 30 days after surgery4
12-item World Health Organization Disability Assessment Schedule 2.0 score (12-item WHODAS 2.0 score)
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) will be employed to evaluate postoperative functional health status. The 12-item version yields a total score ranging from 12 to 60, with higher scores indicating greater disability and poorer health outcomes.
Time frame
within 180 days after surgerySponsors and contacts
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Source ClinicalTrials.gov